1. Technical Field
The present disclosure relates to a method and to an apparatus for facilitating wound closure. More particularly, the present disclosure relates to a device that facilitates closure and/or fixation of the wound.
2. Background of Related Art
Minimally invasive surgery, e.g., laparoscopic, endoscopic, and thoroscopic surgery, has become increasingly popular in recent years. Minimally invasive surgery eliminates the need to cut a large incision in a patient, thereby reducing discomfort, recovery time, and many of the deleterious side effects associated with traditional open surgery.
The initial puncture is usually very small so that a needle or trocar can achieve the desired penetration without excessive damage to tissue. It may be necessary for the initial access hole to be subsequently enlarged to provide a working diameter to permit introduction of surgical instruments and the performance of the desired medical procedure.
Complications with having a larger access hole include leakage of body fluids and substances through the enlarged opening. Moreover, body structures that are being penetrated frequently comprise relatively flaccid membranes or walls such that penetration with a larger sized dilator may result in fascial detachment, i.e., the invagination and separation of the membrane or wall from surrounding tissue structures. Such problems may be exacerbated when the organ, tissue, or cavity being penetrated is diseased such that the membranes or walls are thickened or toughened and resistant to penetration by the dilator that axially engages the tissue.
Various devices and techniques have been developed to provide an enlarged opening while minimizing the negative consequences of having an enlarged opening. One approach for preventing fascial detachment of the internal body organ or structure during the dilation process involves the use of separate anchoring instruments that are placed around the site of penetration and dilation. The technique relies on the placement of multiple separate anchors or toggles peripherally about the site of the primary puncture in order to more strongly attach the body organ to its surrounding fascia. The anchors are attached to lengths of suture that extend through the tracks defined by the separate punctures. The sutures are tensioned in order to hold the wall of the hollow organ against the fascia and subsequently secured outside the body. This approach requires a separate puncture for each anchor and the subsequent suturing of each anchor in place. The technique is therefore relatively time consuming, costly, and subjects the patient to discomfort from the creation of multiple puncture wounds.
A radially expandable access system has become commercially available under the trademark STEP™ and is owned by the assignee of the present application. Certain aspects of the STEP™ access system are described in U.S. Pat. Nos. 5,183,465; 5,431,676; 5,814,058; and 5,827,319, which are assigned to the assignee of the present applications, the contents of which are hereby incorporated by reference herein.
The STEP™ access system includes a pneumoperitoneum needle, an expandable sleeve component which is percutaneously introduced while positioned over the pneumoperitoneum needle, a cannula having a pneumostasis valve permanently affixed at its proximal end, and an obturator which is removably inserted into the cannula. After the needle/sleeve assembly has been percutaneously introduced, and the peritoneal cavity insufflated in the case of laparoscopic procedures, the needle is removed from the sleeve, and the cannula/obturator assembly introduced through the sleeve. The sleeve, which initially has a diameter in the range of 2-3 mm, is expanded by the cannula and obturator to a final diameter which can be selected from 5 mm, 10 mm, or 12 mm. Use of the STEP™ access system facilitates the replacement of the cannula with a larger diameter cannula through a previously introduced sleeve.
After completion of the desired procedure, the instruments used for the procedure including the sleeve are removed, and the wound is sutured closed. A continuing need exists for improved devices and methods for closure of wounds formed to facilitate insertion of access systems.